Shwetha Chetan

Princeton, NJ *****

(M) 646-***-****

Email: ad002p@r.postjobfree.com

EXECUTIVE SUMMARY

Experienced pharmaceutical professional with a decade of industry expertise, specializing in Quality Operations and Analytical Chemistry (approximately 8 years), coupled with 2+ years of proven proficiency in Clinical Study Coordination.

• Led oversight of Contract Manufacturing Organizations (CMOs) and Contract Packaging Organizations (CPOs) for both Innovator and Generic Drug products, with a focus on Quality Operations. Successfully navigated FDA audits and facilitated regulatory submissions.

• Proficient in batch record review and release, APQR, Stability and Retain Sample Management, and handling of Product Complaints.

• Highly process-oriented approach to reviewing Quality documents.

• Accomplished in working within Quality Assurance and QC laboratory environments to support fast-paced business requirements.

PROFESSIONAL EXPERIENCE

PTC Therapeutics, South Plainfield/Hopewell, NJ

Quality Assurance: Sr. Specialist Operations – Americas (Aug 2021 - Present)

• Conducting thorough Quality Assurance review and release of Small Molecules for contract manufacturing, packaging, labeling, and analytical records, ensuring strict adherence to GMP regulations for both Clinical and Commercial supplies.

• Diligently examined API and Drug product (Bulk and Finished) packaging, overseeing the release process to maintain quality standards.

• Assessed Laboratory methods and specifications for analytical procedures related to PTC API, drug product, and packaging materials, upholding stringent quality control.

• Contributed to the development and periodic revisions of Global Standard Operating Procedures (SOPs), including those specific to the Americas region.

• Provided invaluable support to QA operations by consistently preparing metrics, Trend analysis, presentations, and work instructions in alignment with senior management's requirements.

• Overseeing multiple projects and meticulously monitoring all associated activities and project milestones. Promptly identifying and reporting any issues to the relevant management levels.

• Collaborating with external partners to guarantee the precise creation of clinical labels according to the specified requirements.

• Preparing essential clinical labeling and commercial artwork source documentation.

• Carefully reviewing and endorsing label proofs, specifications, and related documents provided by vendors."

• Review and approve of Investigations (Using Fish-bone Diagram and 5-Why’s techniques) and non-conformance, deviations, Temperature excursions.

• Proficient knowledge of quality systems including CAPA, change control, and document management systems like VeevaVault.

• Championed good documentation practices and unwavering commitment to regulatory requirements, ensuring full compliance with PTC's cGMP standards.

• Performing training on Quality and manufacturing SOPs as required and maintaining the Master document Control.

• Ensure activities are in state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management/ Warehouse/Supply Chain/ Manufacturing Operations/QC to ensure that projects are appropriately prioritized.

• Data trending and tracking using Veeva Vault for clinical studies and report creation.

• Broad-based technical knowledge and skills in diverse areas such as Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as Quality operations.

• Supervision on Supplier Qualification activities in alignment with industry standards for clinical and commercial product manufacturing and packaging.

• Gained comprehensive training and coursework, proficient in the fundamental principles and techniques crucial to the production and quality control of cell-based and Gene therapies.

• Assess a diverse range of documents for adherence to established procedures, encompassing SOPs, work instructions, technical documents, logbooks, and forms. Dr. Reddy’s Laboratories, Princeton, NJ

Quality Assurance Americas – Associate (Jun 2018 - Aug 2021)

• Conducted commercial batch record review and release of Small Molecules in an efficient and timely manner.

• Managed Contract Manufacturing and Packaging Organizations (CPOs) to ensure compliance with regulatory requirements, ANDA registration, Company Specification, and Quality Agreement requirements for Small Molecules.

• Facilitated Quarterly Quality Review meetings with CPOs.

• Led continuous improvement efforts in batch record review and release processes, including risk management activities.

• Investigation (Using 5-Why’s), non-conformance and deviations, escalating as necessary.

• Reviewed and approved change controls for Small Molecules on new product launches and rework protocols in compliance with Dr. Reddy’s requirements.

• Review and approve commercial labels and artwork as per specifications of Small Molecules.

• Issued Quality Holds, Releases, and quarantine releases as needed for warehouse inventory.

• Tracked, maintained, and reported on batch record releases and error logs.

• Performing training on Quality and manufacturing SOP’s as required and maintaining the Master document Control.

• Oversight of Supplier Qualification activities in compliance with industry standards. APQR

• Gathered statistics and prepared Annual Product Review Reports for Small Molecules.

• Compiled, organized, analyzed, and reviewed information for APQRs.

• Assessed trends and effectiveness of corrective and preventive actions within the APQR scope.

• Reported findings associated with each APQR and verified the effectiveness of documented actions.

• Data trending and tracking using SAP.

• Interpret results and report creation.

• Reviewed and approved APQRs for OTC products.

Stability and Retain Sample Management

• Prepared stability grids and continuously tracked stability test results.

• Managed reserve samples for OTC drug products.

• Data trending and tracking using SAP.

• Interpret results and report creation.

• Worked on process improvements with offsite testing sites. Product Complaints

• Supported investigations involving consumer complaints.

• Data trending and tracking using SAP.

• Interpret results and report creation.

• Monitored and analyzed finished goods complaints for trends.

• Assisted in SOP writing and execution.

• Supported internal and agency audits.

Appco Pharma LLC. Somerset, NJ

QC Data Reviewer (July 2017 - Jun 2018)

• Reviewed data for various types of samples and reports.

• Conducted internal laboratory audits for compliance.

• Coordinated with QC/QA/Regulatory teams for data accuracy and completeness.

• Assisted in calibration and troubleshooting of analytical instruments. Sigma Pharma Laboratories, LLC. PA

Associate Scientist – Analytical Chemistry (July 2015 to July 2017)

• Conducted testing on various types of samples.

• Ensured adherence to cGMP and quality control standards.

• Performed preventative maintenance, calibration, and troubleshooting of analytical instruments.

• Participated in process improvement initiatives. ISRO (Indian Space Research Organization)

Clinical Research Co-Coordinator (Oct 2010 to Dec 2012)

• Assisted in clinical studies related to Diabetes.

• Coordinated clinical trials, including recruitment and data validation.

• Data trending and tracking, statistical analysis using indigenous software.

• Interpret results and report creation.

• Developed data validation and QA processes for data integrity and security.

• Coordinated project-specific training and documentation. THERAPEUTIC AREAS Worked on projects related to Diabetes for Phase III to IV clinical trials.

EDUCATIONAL QUALIFICATIONS

• Master’s in science: Biochemistry

• Bachelor’s in science: Biotechnology

Trainings:

• GXP practices – Intermediate, DS and DP for small molecules, Cell and Gene therapy

• MySQL/SAP

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